If CytoDyn can't get leronlimab approved, these shareholders have a bold plan to tap Big Pharma

If CytoDyn’s leadership can’t get their lead treatment approved, a group of very optimistic investors want to give it a try.

After weeks of very public infighting (PDF) at the Vancouver, Washington-based biotech, a stockholder group has come forward with a strategic plan to get leronlimab approved in a cancer indication.

To quickly summarize the CytoDyn drama: The FDA smacked the company in May for promoting leronlimab as a promising COVID-19 treatment even though it had failed a late-stage study. A public meltdown followed, with the CEO begging investors to go easy on the regulator that holds the key to the pharmaceutical market. The therapy is also in development for cancer and HIV.

The COVID-19 struggles have pushed the company and its shareholders into a public battle, complete with activist lawsuits, an effort to oust board members and settlements. The efficacy claims even invited scrutiny from the Department of Justice and the Securities and Exchange Commission.

RELATED: CytoDyn's previous HIV filing snafu now on better course after FDA sets them straight

Now, a group of shareholders involved in the failed litigation is taking another approach, through a website called Advancing Leronlimab, to pitch a path forward for the CCR5 antagonist.

The plan suggests that leronlimab could be paired with checkpoint inhibitors like Merck & Co.’s Keytruda, Bristol Myers Squibb’s Opdivo or Roche’s Tecentriq. The plan likens leronlimab to Bristol Myers’ Yervoy, which is often paired with Opdivo. The Big Pharma collects about $1.5 billion a year from the therapy’s combination approvals.

These partner therapies, called immune control point (ICI) inhibitors, act when the tumor begins to resist the main treatment, reactivating the immune system to extend the anti-tumor response.

CytoDyn could capitalize on the popularity of combination treatment trials, which are all the rage in oncology at the moment, the group argues. They suggest that leronlimab would perform the same duty as an ICI, basing their argument on data from previous COVID-19 and HIV trials that suggest the drug can reverse T-cell exhaustion.

RELATED: CytoDyn catches SEC, DOJ scrutiny over public claims about COVID-19 drug's viability

“Leronlimab has an opportunity to be a major replacement option for ICI’s due to toxicity concerns,” the stockholders said.

The therapy avoids major side effects associated with this type of treatment such as pituitary disorders and organ dysfunction, according to the plan. Leronlimab may have opportunity in lung, breast, pancreatic, urothelial and colorectal cancers, the shareholders believe.

The plan suggests that CytoDyn seek out partnerships with Bristol Myers, Roche, AstraZeneca, Pfizer and Regeneron to negotiate potential clinical trial combinations.

“These companies should be amenable to clinical investigation into leronlimab combination once leronlimab proves its efficacy as a CCR5 inhibitor,” the plan states.

Leronlimab is already being tested in 22 solid tumors in a phase 2 clinical trial.

In a statement, CytoDyn said the group involved in creating the plan "have continued to mislead shareholders about their intentions, conflicts of interest and pattern of legal transgressions as they try to effectuate a takeover of CytoDyn’s board." 

The company said the existing leadership is "highly focused on the expeditious development of leronlimab."

Editor's Note: This story was updated at 9:25 a.m. ET on Sept. 27, 2021, to include a statement from CytoDyn.